Pradaxa

New Jersey Supreme Court Review Reinstatement Of Accutane Experts

The New Jersey Supreme Court recently granted petitions and cross-petitions to appeal a state appellate court’s reversal of expert exclusions in the state’s Accutane multicounty litigation and the reinstatement of 2,076 dismissed cases (In Re: Accutane Litigation, C-388 September Term 2017, C-329 September Term 2017 and C-390 September Term 2017, N.J. Sup.) See Mass Tort Nexus Accutane Briefcase Accutane New Jersey State Court Litigation.

Judge Eldon Fallon, overseeing the Xarelto multidistrict litigation, recently denied a motion for a new trial by the plaintiff in the third bellwether trial, where Bayer was found not liable in the Dora Mingo trial that took place in a Mississippi federal court in front of Judge Fallon. He ruled that plaintiff was unsuccessful in presenting new findings, among other things, that the plaintiff’s “newly discovered evidence” is actually cumulative of previously known and admitted evidence (In Re: Xarelto [Rivaroxaban] Products Liability Litigation, MDL Docket No. 2592, E.D. La., 2017 U.S. Dist. LEXIS 205422). See Mass Tort Xarelto Briefcase for the entire Mingo trial transcripts as well as full transcripts of the Orr and Boudreaux trials, XARELTO MDL 2592 US District Court ED Louisiana Including Trial Transcripts.

With the final two pending cases now closed, the Illinois federal judge overseeing the Pradaxa multidistrict litigation on Dec. 11 again recommended that the Judicial Panel on Multidistrict Litigation (JPMDL) terminate the MDL (In Re: Pradaxa [Dabigatran Etexilate]Products Liability Litigation, MDL No. 2385, No. 12-md-2385, S.D. Ill.). After a global settlement was reached in 2014 with defendant Boehringer Ingelheim Pharmaceuticals Inc., the JPMDL suspended the transfer of tag-along actions into the MDL, and now the judge has moved for termination of the Pradaxa MDL. However, there remains over 700 Pradaxa cases pending in the State Court of Connecticut, Complex Litigation Docket, known as “Connecticut Pradaxa Actions”, see Mass Tort Nexus Pradaxa Case Briefcase, Connecticut Consolidated Pradaxa Litigation.

Boehringer To Pay $13.5M To End Off-Label Marketing Claims

Drugmaker Boehringer Ingelheim Pharmaceuticals Inc. has agreed to distribute $13.5 million among all 50 states and the District of Columbia to end allegations that it marketed four of its prescription drugs for off-label uses, attorneys general announced Wednesday.
The settlement would resolve allegations that Boehringer marketed its prescription drugs Micardis, Aggrenox, Atrovent and Combivent for uses that weren’t approved by their labels or backed by scientific evidence. (Getty) The settlement, of which New York will receive about $490,000, would resolve allegations that the drugmaker marketed it products for off-label use, which often leads to unknown or studied adverse events and medical complications for patients taking these drugs for unapproved purposes.

J&J Fined $30 Million Over French Opioid Drug Smear Campaign In Efforts To Sell Fentanyl Patch

France’s antitrust enforcer fined Johnson & Johnson and its Janssen-Cilag unit €25 million ($29.7 million) on Wednesday for hindering the marketing and sale of a generic version of the company’s Durogesic pain patch.The French Competition Authority found that Janssen and J&J had not only successfully delayed a generic competitor for the powerful opioid for several months, but had also done lasting damage by discrediting rival versions of the drug with doctors and pharmacists in a country where medical professionals still remain reluctant to opt for prescribing opioids. The J&J conduct reflects the same claims being asserted against opioid drug makers in the US, where lawsuits have been consolidate into Opiate Prescription Litigation MDL No. 2804, in the US District Court of Ohio, see Mass Tort Nexus Opioid Crisis Briefcase, OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION.

A Pennsylvania appeals court panel on Dec. 15 said a trial judge did not err when remitting a Zimmer Inc. knee verdict to $29.6 million and said it declined to substitute its judgment in place of the jury’s (Margo Polett, et al. v. Public Communications, Inc., et al., No. 80 EDA 2017, Pa. Super., 2017 Pa. Superior Court)

A Pennsylvania state appeals panel on Nov. 28 affirmed the dismissal of 13 Risperdal gynecomastia cases, agreeing with a trial judge that the plaintiffs’ claims are preempted by Michigan’s drug shield law and that the plaintiffs could not prove that the fraud exception

U.S. Supreme Court Asks Solicitor General To Weigh In On Fosamax Preemption

The U.S. Supreme Court on has invited the U.S. solicitor general to express the views of the United States on whether there is “clear and convincing evidence” that the Food and Drug Administration would have rejected a stronger warning about femur fractures from the osteoporosis drug Fosamax (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Supreme Court) This is a unique turn when the Supreme Court is seeking input from an outside agency in what is now a common legal issue placed in front of the court, where dug makers are using the FDA regulatory process as a shield in defending thousands of claims where warnings of drug dangers are not clear or not provided. See Mass Tort Nexus Fosamax Case Briefcase, FOSAMAX MDL 2243 (FEMUR FRACTURE CLAIMS).

Even as Xarelto litigation grows ahead of the first bellwether trial in federal court MDL No. 2592, some plaintiff attorneys are mistakenly turning down cases if the death certificate does not specifically mention internal bleeding or ischemic stroke.

In our consulting practice at Mass Tort Nexus we are often asked if the cause of death listed on a death certificate does not mention bleeding or ischemic stroke deal — is that a fatal obstacle to filing a wrongful death case related to Xarelto, Pradaxa or Eliquis?

In parallel state court litigation in Pennsylvania, Judge Arnold L. New in the Philadelphia Court of Common Pleas amended the master and short form complaint to allow for Ischemic Stroke Claims to be made in that court.

What a death certificate is — and isn’t

A death certificate is document that serves primarily as a public record of an individual’s death. These records are often used in a variety of statistical analysis.

The cause of death (COD) noted on a death certificate is not intended to be an expansive diagnostic review of all medical events that led to the death. In some cases, the person who issued the death certificate may not even be a medical practitioner.

In reviewing blood-thinners Xarelto, Pradaxa and Eliquis cases, the COD listed on the death certificate may not mention bleeding or any other condition known to directly occur as a result of using these drugs however, this does not necessarily mean that it cannot be determined by a preponderance of the evidence that the given anticoagulant did not cause or contribute to the death.

Example: The cause of death on a death certificate may list heart attack, myocardial infarction or cardiac insult as well as other terms that fall under the more general term “heart attack.”

Should one automatically assume that the death, under this circumstance, cannot be attributed to the use of Xarelto, Pradaxa or Eliquis? No!

Bleeding can cause heart attack

Do not allow the cause of death listed on a death certificate be the final determining factor in whether you continue to pursue a wrongful death action.

There is ample evidence in the medical literature “heart attacks” can be secondary to bleeding events. Heart attacks can be caused by sudden significant increases and decreases in blood pressure as well as the heart being deprived of oxygen, delivered by adequate blood flow.

If the death certificate lists any form of “heart attack” as the cause of death, further investigation is warranted to determine whether the use of any of the aforementioned drugs could have reasonably caused or contributed to the heart attack.

A significant bleed within two or three weeks before the heart attack resulting in death will have more likely than not caused or contributed to the heart attack.

A significant bleed can lead to permanent heart damage and can cause or contribute to a heart attack months or even years after the bleeding event. Obviously, the less time there is between the bleeding event and the heart attack makes for a less difficult argument.

It should be noted that in cases where the patient had a history of heart attacks or conditions which are known to lead to heart attacks such as late stage diabetes, for example, may make it more difficult to prevail in your argument.

When analyzing whether the bleeding event may have caused or contributed to the cause of death listed on the death certificate, it is important to understand a basic fact:

Bleeding is never the actual cause of death — events secondary to bleeding are the actual cause of death.

This statement can be difficult to wrap one’s head around as the term “bled to death” is so commonly used and is not inaccurate in the broadest sense. However, from a physiological perspective the true cause of death is always secondary to loss of blood. If insufficient blood volume exists vital organs that are highly dependent on oxygen and fluid volume can quickly fail resulting in death.

The takeaway from this article is: Do not allow the cause of death listed on a death certificate be the determining factor in whether you continue to pursue a wrongful death action.

Once you have a death certificate in hand, review the cause of death listed on the death certificate. After ascertaining the COD listed on the death certificate, as a first step simply Google “Can Bleeding Result in (insert cause of death listed).”

If the cause of death listed a condition that can be attributed to bleeding, then further review of the patient’s pre-death medical records is warranted to determine if there is a strong argument that the bleeding event caused or contributed to the condition listed on the death certificate.

Two Cautions

Late-stage cancers, particularly pancreatic and liver cancer, often result in bleeding regardless of whether the patient is receiving anticoagulant therapy or not. If the cause of death listed is a type of cancer that has a high mortality rate in late stages, then is would be far more difficult to argue that it was more likely than not that the anticoagulant caused the death versus the cancer.

In some cases, the cause of death may be listed as “natural causes” or even “old age.” Although no one dies of natural causes or old age, if such terms are listed as the COD, it may be more difficult, although not impossible, to show that the death was caused by the use of the anticoagulant. To demonstrate that the anticoagulant more likely than not caused or contributed to the death, medical records demonstrating a circumstance that would almost certainly lead to death would be needed.

This article is not intended to be medical or legal advice. Our goal is to provide issues to consider when evaluating Xarelto, Pradaxa and Eliquis cases as well as other cases in which the content of this article may apply.

Mass Tort Litigation has emerged as the only effective check on pharmaceutical and medical device companies that make dangerous products injuring thousands of Americans. Mass tort attorneys have filed 140,000 lawsuits in 250 federal multidistrict litigation dockets as of September 2016.

Many attorneys are expanding their personal injury practices to include mass torts because the US Judicial Panel on Multidistrict Litigation has organized the litigation so effectively against the multi-billion-dollar drug and medical device industry.

“The FDA is not a check or a balance on the pharmaceutical industry,” said Mass Tort Nexus Consultant John Ray, recently teaching a four-day course about mass torts in Fort Lauderdale, FL. “Plaintiff attorneys are the only check on the pharmaceutical industry.”

In recent years mass tort lawyers have recovered $10 billion in settlements for injured Americans: $4.8 billion for Vioxx, $1.8 billion for Yaz, $1.3 billion for the Stryker hip and $2.5 billion for the DePuy hip.

“The drug companies bake these cases into their business model,” Ray said. “Defendants call it a win when they don’t put a warning on their labels, don’t get sued and don’t have to pay a judgment at all. This means they got away with it. That happens a lot.”

When a federal MDL is created, the supervising judge will approve a standard short-form or long-form complaint, plus a plaintiffs’ fact sheet which replaces interrogatories. The consolidation of cases means that a mass tort lawyer can file a notice of appearance and file cases regardless of the jurisdiction of the plaintiff, defendant company or the location of the plaintiff’s attorney.

Criteria for a viable case

Cases that are attracting many mass tort attorneys now involve Xarelto, IVC filters and Pradaxa. Among the many factors determining the viability of a mass tort are:

Statute of limitations: State laws govern when the statute of limitations starts to run, but in most federal litigation, the date that the FDA issues a “black box warning” for a drug marks the date when the time limit begins to run.

Legal viability. In many cases, research will show a connection between a drug and injuries among patients, but specific causation must be proved in a trial. Experts must be found who will survive a Daubert motion to disqualify.

Financial viability of the defendant. While Johnson & Johnson had $46.8 billion in annual income in 2015, some small makers of IVC filters went out of business before they could sell one.

Cost per client acquired. Costs can add up with Facebook advertising, website marketing, and lead generation companies. For example, The Sentinal Group will advertise for clients for a fee of $100,000 to obtain 250 calls for Xarelto plaintiffs, with 1 out of 5 calls leading to a signed client.

Case duration. Mass torts are litigation for the long haul, with the average case lasting 5 years and 4 months before settlement, according to Ray, with 7 years being a good benchmark for the duration of a case.

Case value. An example of a good outcome is with Pradaxa. The average settlement is $162,000. Calculating 40% in gross contingent fees would equal $64,800. Another 7% is deducted ($4,536) for the common benefit to pay the steering committee. Of the remaining fee of $60,204, a 40% referral fee of $24,015 is deducted for the co-counsel that handled the litigation. This leaves a net fee of $36,189 for the attorney who originated the case.

Financial resources. Costs to fund a case can be in the tens of thousands of dollars, with costs reaching hundreds of thousands for members of the plaintiffs steering committee.

Personnel resources. A law firm will have to train a small army of intake specialists to answer incoming calls when advertising is running. Additional personnel will be needed to obtain and review medical records.

Perfect timing

There are three phases of mass tort litigation, and perfect timing will be needed to enter a particular case.

Emerging Phase Cases. In this early phase, the cost to acquire a client is the least expensive, but there many issues of case viability. For example, the courts are still considering motions to consolidate cases involving Abilify and Roundup. With Abilify the FDA has issued a safety warning but not a black box warning. With Roundup the EPA has not classified the herbicide as a carcinogen, but foreign governments have.

Litigation Phase Cases. It is considered an ideal time to enter into a mass tort when the JPML has created a multi-litigation docket (MDL). Some 250 MDLs include mature litigation involving Benicar, Lipitor, Viagra, Xarelto and Zofran, and many legal issues have been settled. The supervising judge will schedule bellwether or test cases for trial.

Settlement Phase Cases. This is the very safest time to enter litigation because all an attorney must do is find qualified plaintiffs. Example cases involve transvaginal mesh, Levaquin and Pradaxa. However at this late phase the cost to acquire a client is at its highest.

“Whatever you do, maintain your single-event plaintiff’s practice,” Ray advised. “You will have to keep paying the costs of a mass tort case until it settles, and you will need a huge cash supply or credit line.”

So far there are 700 cases and climbing in the litigation consolidated in Connecticut, according to mass tort expert John Ray of Mass Tort Nexus in Fort Lauderdale, and plantiffs can file there regardless of the state or original jurisdiction.

Before the first case was tried in the federal MDL, German drug maker Boehringer Ingelheim settled 4,590 cases involving Pradaxa (Dabigatran) for a total of $650 million in May 2014. Patients and their families claimed that Boehringer failed to properly warn them that the drug, which is used to prevent blood clots, caused serious and sometimes fatal bleeding that could not easily be reversed.

Shortly after its release to market in 2011, Pradaxa was surrounded by more than 3,500 reports of serious adverse events. More than 750 of these reports involved the death of a Pradaxa patient. The federal MDL was created in August 2012 and the settlement came only 18 months later. The litigation produced 80 million pages of documents and the deposition of 48 defense corporate witnesses.

The drugs are used to to treat clots and are often used for longer than the standard 3-month treatment period to prevent formation of additional clots, but the comparative safety and effectiveness of extended use is unclear, according PCORI.

Federal Xarelto Litigation is consolidated before US District Judge Eldon Fallon in MDL 2592 and the state litigation is consolidated in the Philadelphia Court of Common Pleas before Judge Arnold New. In the state MDL Judge New has elected to allow “Efficacy Claims” to be filed in that MDL in addition to claims related to uncontrolled bleeding. Judge Fallon has yet to follow suit and may not.

Uncertainty about medications

Venous thromboembolism (VTE) causes more than half 500,000 hospitalizations and more than 100,000 deaths each year in the United States. VTE is typically treated with at least three months of an anticoagulant, or “blood-thinning,” medication. Afterward, patients are often given the option to extend anticoagulant treatment for a longer period to prevent VTE recurrence. Remaining on anticoagulants, however, can lead to serious bleeding complications and can be expensive and inconvenient for patients.

At present, there is much uncertainty about which medication is the best choice for extended VTE treatment, according to PCORI. Choosing the best anticoagulant strategy is particularly difficult when treating people of older age, people who have kidney disease, or people who have high bleeding risk, due to the scant evidence available on the relative benefits and harms in these populations.

The long-term goal of the project is to compare the benefits and harms of different anticoagulant options for the extended treatment of VTE, information that will be critical in helping clinicians and patients personalize their treatment decisions. The study focuses on people who have completed at least three months of anticoagulant treatment for VTE and compares the outcomes of 1) people who stay on anticoagulants with those who stop anticoagulants, and 2) those who are treated with extended warfarin compared with NOAC treatment. PCORI will also examine whether the benefits and harms of treatment differ by age, kidney function, or bleeding risk.

The study will be based in Kaiser Permanente Northern California and Kaiser Permanente Southern California, two large, integrated healthcare delivery systems that provide comprehensive medical care for more than 7.7 million patients in California. PCORI will identify in these health systems all adults treated for VTE from years 2010 to 2015 and collect information from electronic health records on their health history, anticoagulant treatment choices, and clinical outcomes. Next, PCORI will survey patients with VTE treated in more recent years (2014–2016) and measure their self-reported health, well-being, and satisfaction with treatment.

The main outcome of the study is the net benefit of one treatment strategy compared with another, measured in terms of the number of VTE events prevented and the number of bleeding complications induced. Because the study is an observational study of actual clinical care, PCORI will then apply advanced statistical techniques to maximize the validity of the results.

Diagnostics company Alere Inc. announced a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR blood Monitoring Systems.

Patients taking blood thinners like Coumadin, Jantoven, Warfilone (warfarin), Pradaxa (dabigatran), Xarelto (rivaoxaban), or Lovenox (enoxaparin), can to monitor their blood levels at home instead of at a lab, by using the Alere INRatio, INRatio2 PT/INR Monitor System, or INRatio Test Strips (collectively the Alere INRatio Monitoring System) to monitor their international normalized ratio (INR) while undergoing anticoagulation therapy.

The monitor is supposed to perform a simple blood test, letting a patient and doctor doctor know if the medication is working properly or if a dose adjustment is needed.

Over the course of the past two years, Alere invested in the research and development of software enhancements to address the potential, in certain cases, of the system to deliver a result that differs from that of another measurement method.

FDA: Not effective

The FDA notified the company that it believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio device from the market.

Alere seeks an orderly transition for patients requiring anti-coagulation monitoring and will provide a timeline to discontinue the product line. Alere will provide further information on patient transition to patients and healthcare providers. The FDA suggest that patients speak with their healthcare providers prior to making any changes to their current PT/INR monitoring practices.

In other news, Alere Inc. was hit with a securities fraud lawsuit on April 22, accusing it of artificially inflating its share prices ahead of the Feb. 1 announcement of its proposed $5.8 billion acquisition by Abbott Laboratories Inc.

The shareholder lawsuit, filed in federal court in Boston, accused Alere of misleading investors by stating that its financial reporting followed generally accepted accounting principles. The plaintiffs, a group of individual investors, cited a federal probe into the company’s accounting for overseas sales in arguing that Alere had not adhered to those principles.

With the first of 15,000 lawsuits heading to trial on March 13 against the makers of blood-thinner Xarelto, Judge Eldon E. Fallon set a briefing schedule for dispositive motions and Daubert motions for the first two bellwether trials.

For Daubert motions regarding the first two bellwether trials for experts whose depositions are concluded on or before December 15, 2016:

Motions and Briefs: December 30, 2016

Response in Opposition Briefs: January 23, 2017

Reply Briefs: February 3, 2017

Hearing and Argument (if necessary): February 10, 2017

For Daubert motions regarding the first two bellwether trials for experts whose depositions are concluded after December 15, 2016:

Motions and Briefs: February 3, 2017

Response in Opposition Briefs: February 24, 2017

Reply Briefs: March 3, 2017

Hearing and Argument (if necessary): March 8, 2017

14,465 actions have been filed in the federal MDL in Louisiana (up from 10,769 cases in October). Meanwhile, approximately 1,100 claims have been docketed in the Philadelphia Court of Common Pleas, and the number of claims before Judge Arnold New is increasing. The Philadelphia court has set 10 Xarelto cases for bellwether trials for next fall.

Plaintiffs’ attorneys are encouraged by actions taken with another new-generation blood thinner called Pradaxa that shares many similarities with the drug Xarelto. Rather than go to trial, Pradaxa’s maker opted to settle all the lawsuits with a $650 million settlement in Dec. 2014, with individual settlements ranging up to $500,000. It is the hope of many of the plaintiffs in the Xarelto cases that they will also be the beneficiaries of a settlement by the makers of Xarelto.